10 mg orodispersible tablets
loratadine
What Loratadine Sandoz is and what it is used for
Loratadine Sandoz is an anti- allergy . It can help you control your allergic reaction and its symptoms.
Loratadine Sandoz relieves symptoms associated with e.g. hay fever and allergy to dust mites (allergic rhinitis ) such as sneezing, runny or itchy nose, itchy throat, and itchy, red, or watery eyes.
Loratadine Sandoz is also used to relieve symptoms such as itching and hives (associated with chronic urticaria of unknown cause).
Loratadine contained in Loratadine Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Loratadine Sandoz
Do not take Loratadine Sandoz
- if you are allergic to loratadine or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before taking Loratadine Sandoz:
- if you have any serious liver disease.
- If you are going to undergo a spot test, it may be necessary to stop taking this medicine at least 2 days before the test to ensure that the test result is correct.
Children
Loratadine Sandoz is not recommended for use in children below 2 years of age as efficacy and safety have not been established. Do not give Loratadine Sandoz to children between 2 and 12 years of age weighing less than 30 kg. There are other, more appropriate formulations.
Other drugs and Loratadine Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The interaction may occur if loratadine is used concomitantly with other drugs that reduce the function of certain liver enzymes, leading to increased levels of loratadine. These drugs can increase the incidence of side effects.
Loratadine Sandoz with food, drink and alcohol
Loratadine Sandoz orodispersible tablet does not need to be taken with water or any other liquid. In addition, Loratadine Sandoz can be taken with or without food.
Loratadine Sandoz has not been shown to increase the effects of alcohol.
Pregnancy, breastfeeding and fertility
The use of Loratadine Sandoz is not recommended during breastfeeding and in pregnancy.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
If you are breastfeeding, Loratadine Sandoz is not recommended as loratadine is excreted in human milk.
Driving and using machines
In clinical trials examining the ability to drive, no deterioration was seen in people receiving loratadine. At the recommended dose, Loratadine Sandoz is not expected to make you drowsy or less alert. In very rare cases, however, some people may experience drowsiness, which may affect their ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Loratadine Sandoz contains aspartame, lactose, sorbitol, sodium and sulfites
This medicine contains 0.5 mg aspartame per orodispersible tablet. Aspartame is a source of phenylalanine. It can be harmful if you have phenylketonuria (PKU), a rare, inherited disease that leads to the accumulation of high levels of phenylalanine in your body.
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor or pharmacist before taking this medicine.
This medicine contains up to 7 mg sorbitol per orodispersible tablet.
This medicine contains less than 1 mmol (23 mg) sodium per orodispersible tablet, it is essentially ‘sodium-free ‘.
This medicine contains sulfites which, in rare cases, can cause severe hypersensitivity reactions and convulsions in the trachea.
How to take Loratadine Sandoz
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Loratadine Sandoz orodispersible (‘melt in the mouth’) tablets are intended for oral use and are applied to the tongue (see below).
Loratadine Sandoz orodispersible tablet breaks easily so you should handle the tablets carefully and only with dry hands.
Usage:
Loratadine Sandoz orodispersible tablet comes in contact with the saliva in your mouth and can therefore be taken without water. It has a sweet orange taste.
The recommended dose is:
Adults and adolescents (12 years and older): Take a Loratadine Sandoz 10 mg
orodispersible tablet once a day.
Children 2 to 12 years of age weighing more than 30 kg: Take a Loratadine Sandoz 10 mg orodispersible tablet once a day.
Children under 2 years of age or weighing less than 30 kg: Loratadine Sandoz orodispersible tablet should not be given to children under 2 years of age or older children weighing less than 30 kg.
Patients with severe hepatic impairment: Adults and children weighing more than 30 kg should start with a lower dose: Take a Loratadine Sandoz 10 mg orodispersible tablet every other day.
Elderly patients and patients with renal impairment: No dose adjustment is required.
Duration of treatment:
Take Loratadine Sandoz orodispersible tablet for as long as your doctor has told you to.
If you take more Loratadine Sandoz than you should
Take Loratadine Sandoz only as prescribed. If you have ingested too much medicine or if e.g. If a child has ingested the medicine, contact a doctor, hospital, or the Poison Information Center (tel. 112) by mistake for assessment of the risk and advice. Taking more Loratadine Sandoz than recommended can cause drowsiness, palpitations, and headaches.
If you forget to take Loratadine Sandoz
If you forget to take your tablet on time, take it as soon as possible, then return to your regular dosing schedule. Do not take a double dose to make up for a forgotten tablet.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most commonly reported adverse reactions in adults and children over 12 years of age are:
- drowsiness
- headache
- increased appetite
- sleeping problems.
The most commonly reported adverse reactions in children aged 2 to 12 years are:
- headache
- nervousness
- fatigue.
The following very rare side effects (may affect up to 1 in 10,000 people) have also been seen after the marketing of loratadine:
- severe allergic reaction (including swelling)
- dizziness
- cramps
- irregular or fast heartbeat
- nausea
- dry mouth
- upset stomach
- liver problem
- hair loss
- rash
- fatigue.
Has been reported (occurs in the unknown number of users):
- weight gain.
How to store Loratadine Sandoz
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiration date is the last day of the specified month.
Store in the original package. Moisture sensitive.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is loratadine.
An orodispersible tablet contains 10 mg of loratadine .
The other ingredients are orange-flavored sweeteners (containing sulfites), aspartame (E951), anhydrous citric acid (E330), colloidal anhydrous silica (E551), dried corn starch, anhydrous lactose, magnesium stearate (E470b), croscarmellose sodium (E4688 E2), mannitol (E46) sorbitol (E420), crospovidone, colloidal hydrated silica (E551), polysorbate 80 (E433), povidone (E1201), microcrystalline cellulose (E460).
What the medicine looks like and contents of the pack
Loratadine Sandoz orodispersible tablet is white, round and flat.
The packs contain 4, 7, 10, 12, 14, 15, 20, 21, 28, 30 or 100 orodispersible tablets, packed in aluminum / aluminum blisters with perforations between each tablet.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer:
Lek Pharmaceuticals dd, Verovškova 57, 1526 Ljubljana, Slovenia